Methods: Patients will undergo percutaneous needle biopsies from either primary or
metastatic sites to obtain tumor tissue. Patients in whom sufficient tumor mRNA has been
amplified by PCR to transfect the assigned dendritic cell dose will undergo leukapheresis
and peripheral blood mononuclear cells will be cultured in vitro for 7 days with GM-CSF and
IL-4 to generate precursor derived dendritic cells. Dendritic cells will then be
cryopreserved for later use. On the day the patient returns to receive his infusion (weeks
0, 2, and 4) the dendritic cells will be thawed, reconstituted, and transfected with
amplified total tumor mRNA. Patients will receive a total of 3 treatments consisting of
combined I.V. and I.D. injections, each on study week 0, 2, and 4. Repeat leukapheresis will
be performed 2 weeks after the last dose to determine immune function. PSA levels will be
measured prior to the start of treatment and 2 weeks following the last infusion. Patients
who do not receive therapy due to a failure to produce sufficient RNA or dendritic cells
will be replaced in order to assess toxicity.
Data Analysis: 1. To determine the short and long term toxicities associated with
administration of tumor RNA dendritic cells in patients with metastatic prostate cancer. 2.
To determine feasibility of dendritic cell vaccine generation according to the proportion of
patients for whom sufficient cells are generated to provide treatment. 3. To determine the
cellular immune response to intravenous infusion of tumor RNA dendritic cells. 4. To measure
the PSA response of patients with metastatic prostate cancer to intravenous infusion of
tumor RNA dendritic cells.
Primary Purpose: Treatment
Johannes Vieweg, M.D.
United States: Federal Government
|Duke University Medical Center||Durham, North Carolina 27710|